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TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium

Primary Purpose

Bladder Neoplasms, Ureteral Neoplasms, Urethral Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TOCOSOL Paclitaxel
Sponsored by
Achieve Life Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologic diagnosis of transitional cell carcinoma (TCC) of the urothelium including bladder, renal pelvis, ureter, or urethra Stage IV disease One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease Adequate hematologic function (ANC >/= 1500 cells/mm3 & platelet count >/= 100,000/mm3) Serum creatinine </= 2.0 mg/dL Total bilirubin </= 1.5 mg/dL SGOT & SGPT </= 3 times upper limit of institutional normal values PT (INR) & PTT within institutional lab normal range Karnofsky performance status of 60-100% At least one unidimensionally measurable lesion, suitable for radiographic evaluation of disease response, consistent with RECIST criteria Signed IRB/EC approved Informed Consent Life expectancy of at least 12 weeks 18 years of age or older Fully recovered from any previous surgery Not pregnant and willing to use a medically effective form of contraception during periods of chemotherapy treatment (both males and and females) Agree not to take vitamin E supplementation while receiving study medication Willing to participate in requested follow-up evaluations Willing to permit treating physicians to provide information to Sonus regarding disease status and survival for 2 years after first dose of study drug Exclusion Criteria: Prior taxane-containing chemotherapy including Taxol(R) (paclitaxel) or generic equivalent, or Taxotere(R) (docetaxel) Peripheral neuropathy NCI-CTC grade 2 or greater Wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug An investigational agent within 4 weeks of first dose of study drug Concurrent anticonvulsants known to induce P450 isoenzymes Patients who are pregnant or lactating A history of carcinoma of another primary site (other than non-melanoma skin cancers or carcinoma-in-situ of the cervix) within the previous 5 years, unless metastatic disease has been biopsied and documented to be TCC Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic TCC Brain metastasis Active bowel obstruction Active, serious infection or other serious medical problems (other than TCC) likely to impair completion of the study protocol

Sites / Locations

  • University of Maryland Medical Center/Greenbaum Cancer Center
  • Cleveland Clinic Foundation
  • University of Washington/Seattle Cancer Care Alliance

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

Time to treatment failure
Time to progression
Progression free survival
Overall survival at 2 years

Full Information

First Posted
February 10, 2004
Last Updated
June 2, 2009
Sponsor
Achieve Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00077688
Brief Title
TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium
Official Title
A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(TM) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) in Patients With Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma of the Urothelium
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Achieve Life Sciences

4. Oversight

5. Study Description

Brief Summary
Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma of the urothelium

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Neoplasms, Ureteral Neoplasms, Urethral Neoplasms, Carcinoma, Transitional Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TOCOSOL Paclitaxel
Primary Outcome Measure Information:
Title
Objective response rate
Secondary Outcome Measure Information:
Title
Time to treatment failure
Title
Time to progression
Title
Progression free survival
Title
Overall survival at 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic diagnosis of transitional cell carcinoma (TCC) of the urothelium including bladder, renal pelvis, ureter, or urethra Stage IV disease One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease Adequate hematologic function (ANC >/= 1500 cells/mm3 & platelet count >/= 100,000/mm3) Serum creatinine </= 2.0 mg/dL Total bilirubin </= 1.5 mg/dL SGOT & SGPT </= 3 times upper limit of institutional normal values PT (INR) & PTT within institutional lab normal range Karnofsky performance status of 60-100% At least one unidimensionally measurable lesion, suitable for radiographic evaluation of disease response, consistent with RECIST criteria Signed IRB/EC approved Informed Consent Life expectancy of at least 12 weeks 18 years of age or older Fully recovered from any previous surgery Not pregnant and willing to use a medically effective form of contraception during periods of chemotherapy treatment (both males and and females) Agree not to take vitamin E supplementation while receiving study medication Willing to participate in requested follow-up evaluations Willing to permit treating physicians to provide information to Sonus regarding disease status and survival for 2 years after first dose of study drug Exclusion Criteria: Prior taxane-containing chemotherapy including Taxol(R) (paclitaxel) or generic equivalent, or Taxotere(R) (docetaxel) Peripheral neuropathy NCI-CTC grade 2 or greater Wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug An investigational agent within 4 weeks of first dose of study drug Concurrent anticonvulsants known to induce P450 isoenzymes Patients who are pregnant or lactating A history of carcinoma of another primary site (other than non-melanoma skin cancers or carcinoma-in-situ of the cervix) within the previous 5 years, unless metastatic disease has been biopsied and documented to be TCC Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic TCC Brain metastasis Active bowel obstruction Active, serious infection or other serious medical problems (other than TCC) likely to impair completion of the study protocol
Facility Information:
Facility Name
University of Maryland Medical Center/Greenbaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Washington/Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium

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